Slide 1: Slide 1
Slide 2: Forward-looking statements
This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, str
Slide 3: Roche Q1 2022 Sales
Roche Q1 2022 Sales Basel, 25 April 2022
Slide 4: Group
Group Severin Schwan Chief Executive Officer
Slide 5: Q1 2022 performance; Outlook
Q1 2022 performance Outlook
Slide 6: Q1 2022: Strong performance for Pharma and Diagnostics
Q1 2022: Strong performance for Pharma and Diagnostics Strong Group sales +11% driven by both divisions • Pharma performing well (+6%) and delivering on current products and new launches • Diagnostics maintaining growth momentum (+24%) including strong base business growth (+10%) Portfolio rejuvenat
Slide 7: Q1 2022: Group sales growth driven by strong performance in both divisions
Q1 2022: Group sales growth driven by strong performance in both divisions 2022 2021 Change in % CHFbn CHFbn CHF CER Pharmaceuticals Division 11.2 10.6 5 6 Diagnostics Division 5.3 4.3 22 24 Roche Group 16.4 14.9 10 11 CER=Constant Exchange Rates; totals may include differences due to rounding 7
Slide 8: Q1 2022: Group sales +11% driven by both divisions
Q1 2022: Group sales +11% driven by both divisions 16% 14%* 14% 13% 12% 12% 10% 9% 9% 11% 8% 7% 7% 7% 6% 6% 6% 6% 6% 6% 7% 8% 8% 4% 6% 4% 5% 5% 4% 4% 3% 2% 3% 3% 1% 1% 0% -2% -4% -6% -4% AHR1 impact -8% -10% COVID-19 impact Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q
Slide 9: Q1 2022: Strong underlying business momentum
Q1 2022: Strong underlying business momentum +11% at CER CHFm Diversification of Roche business +449 -568 + 749 -155 Q1 2017 Q1 2022 + 304 +736 CHF 12.9bn CHF 16.4bn AHR AHR 16,445 14,930 Diagnostics Oncology Other pharma AHR Ophthalmology Neuroscience Infectious diseases Hemophilia A Q1 Diagnostics
Slide 10: Q1 2022 performance; Outlook
Q1 2022 performance Outlook
Slide 11: 2022 sales outlook confirmed
2022 sales outlook confirmed Sales drivers1 Pharma: New products with accelerating growth Diagnostics: Base business with strong growth • Guidance stable to low-single digit group sales growth • Group sales to grow high-single digit if COVID-19 sales and AHR AHR2 biosimilars: Roughly CHF -2.5 bn sal
Slide 12: 2022: Upcoming newsflow
2022: Upcoming newsflow Pharma Diagnostics Vabysmo in DME/nAMD Automated BenchMark immunohistochemistry/in situ Susvimo in nAMD ULTRA PLUS hybridization advanced staining Ongoing and platform upcoming Polivy in 1L DLBCL launches High capacity pathology slide mosunetuzumab in FL Upcoming DP600 scanne
Slide 13: First Roche ESG event focusing on access to healthcare
First Roche ESG event focusing on access to healthcare Our 10-year ambitions to be achieved by 2030 Pharmaceuticals: Double medical advances at less costs to society Roche ESG Event on May 16 Access to Healthcare Diagnostics: Double patient access to novel, high-medical-value diagnostics solutions 1
Slide 14: 2022 outlook
2022 outlook Group sales growth1 • Stable to low-single digit • Low- to mid-single digit (including accretion of Core EPS growth1 4.4%p from share repurchase) Dividend outlook • Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER) 14
Slide 15: Pharmaceuticals Division
Pharmaceuticals Division Bill Anderson CEO Roche Pharmaceuticals
Slide 16: Q1 2022: Pharmaceuticals Division sales
Q1 2022: Pharmaceuticals Division sales Good growth momentum 2022 2021 Change in % CHFm CHFm CHF CER Pharmaceuticals Division 11,159 10,600 5 6 United States 5,489 5,292 4 2 Europe 2,072 2,175 -5 -1 Japan 1,337 852 57 69 International 2,261 2,281 -1 0 CER=Constant Exchange Rates 16
Slide 17: Q1 2022: Continued Pharma portfolio rejuvenation
Q1 2022: Continued Pharma portfolio rejuvenation Ronapreve 272% Ocrevus 18% Hemlibra 30% Evrysdi 189% Phesgo 410% Alecensa 23% Tecentriq 8% Kadcyla 9% Polivy 89% Xolair 9% Enspryng 216% Actemra / RoActemra 3% Vabysmo n/a Perjeta 1% Gazyva 7% Esbriet -6% US TNKase / Activase -20% Europe Lucentis -26%
Slide 18: Q1 2022: Oncology portfolio rejuvenation progressing well
Q1 2022: Oncology portfolio rejuvenation progressing well YoY CER growth HER2 franchise Phesgo (+410%) • Kadcyla (+9%) with growth ex-US due to adjuvant BC HER2 franchise Herceptin Perjeta (+1%) +1% • Perjeta (+1%) growth cannibalized by successful Phesgo launch Kadcyla (+9%) Tecentriq +8% • Phesgo
Slide 19: HER2 franchise: Phesgo with strong global launch
HER2 franchise: Phesgo with strong global launch Perjeta conversion rate approaching 25% in early launch countries Phesgo cutting administration time & costs Global Perjeta conversion rate** 24% Volume (vials) Phesgo • Phesgo administration results in significantly reduced healthcare costs and resou
Slide 20: Tecentriq overview: Adjuvant program to read out in 2022
Tecentriq overview: Adjuvant program to read out in 2022 Tecentriq Q1 update CHFm YoY CER growth • US: Sales still impacted by label changes 1,000 • Japan: Sales impacted by mandatory price cut +23% 900 Lung franchise (NSCLC, SCLC) +31% +17% +8% 800 +26% +49% +35% • EU: Growth driven by 1L SCLC; Pos
Slide 21: Hemophilia A franchise: Hemlibra accepted as new standard of care
Hemophilia A franchise: Hemlibra accepted as new standard of care 34% US/EU-5 patient share reached CHFm YoY CER growth 1,000 Hemophilia Q1 update 900 +38% +30% • Nearly 17,000 patients currently treated globally 800 +37% +33% +58% • Hemlibra continues to penetrate across all approved 700 +57% +45%
Slide 22: Immunology franchise: Still moved by COVID-19
Immunology franchise: Still moved by COVID-19 CHFm YoY CER growth Immunology Q1 update 2,500 +6% +9% Actemra (+3%) -5% -2% 2,000 • Remains leading RA monotherapy in EU-5 • Shift from IV to SC continues with SC sales accounting for 1,500 >50% 1,000 • Around 50% of IV sales expected to be due to COVID
Slide 23: MS franchise: Ocrevus global market share reaches 20%
MS franchise: Ocrevus global market share reaches 20% CHFm YoY CER growth 1,500 +18% Q1 update +7% +25% 1,250 +37% +16% +31% • US/EU still impacted by COVID-19 +38% +55% +12% +10% • Mitigation plans for late stage MS development programs 1,000 +48% 67% +59% initiated due to situation in Ukraine/Russ
Slide 24: SMA franchise: Evrysdi with strong US and EU launches
SMA franchise: Evrysdi with strong US and EU launches Most prescribed treatment in the US with >20% share; Germany with >30% share CHFm YoY CER growth 250 Q1 update +189% +347% • ~5,000 patients treated world wide (commercial, clinical 200 trials, compassionate use) >500% 150 • US: Growth driven by
Slide 25: SMA franchise: New data in presymptomatic SMA
SMA franchise: New data in presymptomatic SMA Indication extension for <2 months of age filed with FDA and EMA Ph II (RAINBOWFISH): 1 year interim results in infants (<2 months of age) 4 infants with 2 SMN2 copies: • Most infants treated for >12 months achieved near-maximum CHOP-INTEND scores • Most
Slide 26: Ophthalmology franchise: Follow-up data for Vabysmo in DME
Ophthalmology franchise: Follow-up data for Vabysmo in DME Proportion of patients achieving Q16W dosing increases to ≥ 60% at week 96 Ph III (YOSEMITE, RHINE) in DME: Dosing intervals of patients at year 1 and 2 52 weeks 96 weeks YOSEMITE RHINE YOSEMITE RHINE • Anti-VEGF/Ang2 bispecific mAb with new
Slide 27: Ophthalmology franchise: Follow-up data for Susvimo in nAMD
Ophthalmology franchise: Follow-up data for Susvimo in nAMD Vision and anatomical outcomes maintained through year 2 Ph III (ARCHWAY) in nAMD: 2-year results for Susvimo Q24W dosing BCVA change from baseline CPT change from baseline • First eye implant with continuous drug delivery offering 6-month
Slide 28: 2022: Key late-stage newsflow and upcoming IR events
2022: Key late-stage newsflow* and upcoming IR events Compound Indication Milestone Vabysmo nAMD/DME US/EU approval US Susvimo nAMD EU approval mosunetuzumab 3L+ FL US/EU approval Regulatory Tecentriq Adjuvant NSCLC EU approval Hemlibra Mild to moderate hemophilia A EU approval Polivy + R-CHP 1L DLB
Slide 29: Diagnostics Division
Diagnostics Division Thomas Schinecker CEO Roche Diagnostics
Slide 30: Q1 2022: Diagnostics Division sales
Q1 2022: Diagnostics Division sales Sales increase of +24% driven by COVID-19 testing and base business 2022 2021 Change in % CHFm CHFm CHF CER Diagnostics Division 5,286 4,330 22 24 Core Lab1 1,896 1,786 6 8 Point of Care1 1,466 806 82 84 Molecular Lab1 1,189 996 19 21 Diabetes Care 417 460 -9 -7 P
Slide 31: Q1 2022: Diagnostics Division regional sales
Q1 2022: Diagnostics Division regional sales Very strong growth in all regions; rapid antigen test sales contributing to US growth North America +59% EMEA1 ~32% of divisional sales +2% ~36% of divisional sales Asia Pacific Latin America +34% +9% ~27% of divisional sales ~5% of divisional sales Growt
Slide 32: Q1 2022: Diagnostics Division highlights
Q1 2022: Diagnostics Division highlights Strong growth despite a high base in Q1 2021 CHFbn YoY CER growth +8% • Immunodiagnostics (+11%) Core Lab1,3 • Clinical Chemistry (+8%) • POC Immunodiagnostics (+107%) Point of Care3 +84% • POC Molecular3 (+83%) Molecular Lab3 +21% • Virology (+31%) • Blood g
Slide 33: Diagnostics Division sales growth by quarter
Diagnostics Division sales growth by quarter Very strong COVID-19 and base business growth 55% 48% 1 Diagnostics Division sales growth 28% 31% Routine sales growth 1 24% 18% 17% 18% 8% 10% 5% 2% 11% 1% -2% 9% -5% Q1 20 Q2 20 Q3 20 Q4 20 Q1 21 Q2 21 Q3 21 Q4 21 Q1 22 -17% COVID- Q1: 0.1bn Q2: 0.6bn Q
Slide 34: cobas 5800/6800/8800 molecular menu expansion driving growth
cobas® 5800/6800/8800 molecular menu expansion driving growth Further growing the installed base in 2022 Donor Screening Blood Borne Disease Sexual Health Transplant Respiratory Antimicrobial Stewardship MPX HIV-1 HPV CMV Flu A/B & RSV (OMNI) MTB-RIF/INH WNV HBV CT/NG EBV MTB C.diff DPX HCV TV/MG BK
Slide 35: Upcoming launch of cobas SARS-CoV-2 DUO
Upcoming launch of cobas® SARS-CoV-2 DUO Providing accurate diagnosis of SARS-CoV-2 infection for proper patient management Dual target PCR design concept for accurate quantification Dual target design in SARS-CoV-2 virus specific region, for robust • Provide qualitative result of SARS-CoV-2 detecti
Slide 36: TIB-Molbiol SARS-Cov-2 menu for tracking virus evolution
TIB-Molbiol SARS-Cov-2 menu for tracking virus evolution Detecting major variants in hours vs a week for sequencing BA.3 X.F BA.4 BA.5 BA.1 & BA1.1 Delta X.E BA2 & BA2.2 >10 tests to differentiate all relevant variants 36
Slide 37: Roche Serum Work Area menu expansion driving future growth
Roche Serum Work Area menu expansion driving future growth >240 assays running on >100k installed cobas® SWA instruments Broad IM + CC assay menu Launched in 2021 & upcoming launches in 2022 Immuno chemistry assays Clinical chemistry assays EBV EBNA IgG (CE) IGRA SARS-CoV-2 (CE) Fentanyl5 (CE, US) A
Slide 38: Alzheimer's disease IVD blood tests development
Alzheimer’s disease IVD blood tests development Enabling access to Alzheimer’s disease modifying therapies Non-AD patients1 Patients undergoing initial evaluation for • pTau 181 and ApoE4 have been selected based on clinical non-specific cognitive decline AD patients1 performance and robustness Step
Slide 39: Roche Analyst Event on Diagnostics Division at AACC 2022
Roche Analyst Event on Diagnostics Division at AACC 2022 Chicago, Palmer House hotel, July 26, 6-7:15pm CDT AACC = Annual Scientific Meeting and Clinical Lab exposition 39
Slide 40: Key launches 2022
Key launches 2022 Area Product Description Market Automated immunohistochemistry/in situ hybridization (ISH) advanced staining platform with BenchMark ULTRA PLUS US & CE Pathology Lab enhanced software capabilities, workflow and testing efficiency DP600 High capacity pathology slide scanner for high
Slide 41: Finance
Finance Alan Hippe Chief Financial Officer
Slide 42: Q1 2022: Highlights
Q1 2022: Highlights Sales • Group sales growth of +11% due to strong performance in Pharmaceuticals and Diagnostics division • Pharma delivering well across entire portfolio; Diagnostics continuing with strong results in double-digit range Currency impact on sales • Slightly negative currency impact
Slide 43: Q1 2022: Group Sales
Q1 2022: Group Sales CER Group sales increase of +11% driven by Diagnostics Division & Chugai (Ronapreve) +2% -1% 0% +69% +24% +11% +10% Pharma Division +24% +6% -155 +1,040 1,670 1,515 +569 +80 -13 -6 1 United States Europe Intl. Chugai Dia Division Group Fx ¹ Group (Japan) CHF Absolute values in C
Slide 44: Q1 2022: Strong underlying business momentum
Q1 2022: Strong underlying business momentum 2022 outlook on COVID-19 related sales (+5bn) and AHR erosion (-2.5bn) confirmed +11% at CER CHFm +449 -568 + 749 -155 + 304 +736 16,445 14,930 Q1 Diagnostics Diagnostics Pharma Ronapreve AHR Fx Q1 base COVID-19 underlying sales erosion1 2021 business sal
Slide 45: Novartis share repurchase: CHF 19bn bridge loan largely refinanced and repaid
Novartis share repurchase: CHF 19bn bridge loan largely refinanced and repaid 19,0 5,5 3,0 CHF bn 4,6 3,3 2,6 Initial bridge USD 6bn CHF 3bn USD 5bn Roche Liquid funds Balance outstanding Loan (Dec 21) (Feb 22) (Mar 22) & CPs (Apr 22) • Roche issued in total USD 11bn and CHF 3bn of bonds since Decem
Slide 46: Exchange rate impact on sales growth
Exchange rate impact on sales growth Slightly negative impact mainly from EUR, JPY and TRY partially offset by USD +0.2p +1.0p -0.7p +0.1p -0.9p -0.1p -0.6p CER CHF sales growth sales growth Q1 2022 Q1 2022 vs. vs. Q1 2021 +11.2% +10.2% Q1 2021 CER EUR APAC USD LATAM JPY Other Other CHF Europe CER=C
Slide 47: 2022 currency impact
2022 currency impact CHF / USD +2% +2% +1% +1% Average YTD 2022 Assuming the 31 March 2022 exchange rates remain 0.92 0.92 0.92 0.92 stable until end of 2022, 0.90 0.91 0.91 0.91 2022 impact1 is expected to be (%p): Average YTD 2021 0.92 0.92 0.93 0.92 0.92 0.92 0.92 0.92 0.92 0.92 0.92 0.92 Q1 HY S
Slide 48: First Roche ESG event focusing on access to healthcare
First Roche ESG event focusing on access to healthcare Our 10-year ambitions to be achieved by 2030 Pharmaceuticals: Double medical advances at less costs to society Roche ESG Event on May 16 Access to Healthcare Diagnostics: Double patient access to novel, high-medical-value diagnostics solutions 1
Slide 49: 2022 outlook
2022 outlook Group sales growth1 • Stable to low-single digit • Low- to mid-single digit (including accretion of Core EPS growth1 4.4%p from share repurchase) Dividend outlook • Further increase dividend in Swiss francs 1 At Constant Exchange Rates (CER) 49
Slide 50: Doing now what patients need next
Doing now what patients need next
Slide 51: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 52: Changes to the development pipeline
Changes to the development pipeline Q1 2022 update New to phase I New to phase II New to phase III New to registration 6 NMEs: 1 NME: 1 NME (EU): RG6344 BRAF inhibitor (3) – solid tumors RG6084 PDL1 LNA – HBV RG6026 glofitamab – 3L+ DLBCL RG6333 CD19xCD28 + glofitamab – r/r NHL RG6163 NME – psychiat
Slide 53: Roche Group development pipeline
Roche Group development pipeline Phase I (49 NMEs + 11 AIs) Phase II (22 NMEs + 13 AIs) RG6007 HLA-A2-WT1 x CD3 AML CHU FIXa x FX haemophilia RG6026 glofitamab + chemo 1L ctDNA high risk DLBCL RG6026 glofitamab monotherapy & combos heme tumors CHU glypican-3 x CD3 solid tumors tiragolumab + T NSCLC
Slide 54: Roche Group development pipeline
Roche Group development pipeline Phase III (10 NMEs + 40 AIs) Registration US & EU (4 NMEs + 9 AIs) Kadcyla + T 2L+ HER-2+ PD-L1+ mBC Venclexta r/r MM t(11:14) RG6013 Hemlibra1 mild to moderate hemophilia A RG3502 RG7601 Kadcyla + T HER-2+ eBC high-risk Venclexta + azacitidine 1L MDS RG6026 glofitam
Slide 55: NME submissions and their additional indications
NME submissions and their additional indications semorinemab Projects in phase II and III RG6100 Alzheimer’s brain shuttle glofitamab + chemo RG6026 RG6102 gantenerumab 2L DLBCL Alzheimer’s glofitamab + chemo New Molecular Entity (NME) Metabolism bepranemab RG6026 1L ctDNA+ high risk RG6416 Addition
Slide 56: AI submissions for existing products
AI submissions for existing products Projects in phase II and III New Molecular Entity (NME) Metabolism Xolair Additional Indication (AI) Neuroscience RG3648 food allergy Oncology / Hematology Ophthalmology Immunology Other Xofluza Infectious Diseases RG6152 direct transmission Xofluza RG6152 influe
Slide 57: Major pending approvals 2022
Major pending approvals 2022 US EU China Japan-Chugai Xofluza Susvimo (PDS) Rozlytrek Tecentriq RG6152 influenza pediatric RG6321 wAMD RG6268 ROS1+ NSCLC RG7446 NSCLC adj Filed March 2020 Filed April 2021 Filed Oct 2021 Filed July 2021 Evrysdi Vabysmo (faricimab) Rozlytrek Hemlibra RG7916 SMA presym
Slide 58: Major granted approvals 2022
Major granted approvals 2022 US EU China Japan-Chugai Vabysmo (faricimab) Tecentriq Actemra RG7716 DME RG7446 NSCLC adj RG1569 COVID-19 pneumonia Jan 2022 March 2022 Jan 2022 Vabysmo (faricimab) Actemra Vabysmo (faricimab) RG7716 wAMD RG1569 RA SC RG7716 DME Jan 2022 April 2022 March 2022 Actemra Va
Slide 59: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 60: Hemophilia: Hemlibra
Hemlibra Factor VIII mimetic for treatment of hemophilia A Hemophilia A patients Hemophilia A patients with and without inhibitors to Factor VIII, dosing Indication without inhibitors to factor VIII every 4 weeks Phase III Phase III Phase/study HAVEN 3 HAVEN 4 # of patients N=135 N=46 Patients on FV
Slide 61: Hemophilia: Hemlibra
Hemlibra Factor VIII mimetic for treatment of hemophilia A Hemophilia A mild to moderate patients without inhibitors to Indication Hemophilia A patients with and without inhibitors to Factor VIII Factor VIII Phase III Phase III Phase/study HAVEN 5 HAVEN 6 # of patients N=85 N=70 Patients with Hemoph
Slide 62: Oncology: Alecensa
Alecensa New CNS-active inhibitor of anaplastic lymphoma kinase Treatment-naïve Indication Adjuvant ALK+ NSCLC ALK+ advanced NSCLC Phase III Phase III Phase/study ALEX ALINA # of patients N=286 N=255 ARM A: Alecensa 600mg BID ARM A: Alecensa 600mg BID Design ARM B: Crizotinib 250mg BID ARM B
Slide 63: Oncology: Kadcyla
Kadcyla First ADC for HER2-positive breast cancer HER2-positive early breast cancer (BC) 2L+ HER-2 positive PD-L1 positive metastatic HER2-positive early breast cancer (BC) Indication high-risk patients breast cancer (mBC) high-risk patients Phase III Phase III Phase III Phase/study KATHERINE KATE 3
Slide 64: Oncology: Perjeta
Perjeta First-in-class HER2 dimerization inhibitor Indication Adjuvant HER2-positive breast cancer (BC) HER2-positive early breast cancer (BC) subcutaneous co-formulation Phase III Phase III Phase II Phase/study APHINITY FeDeriCa PHranceSCa # of patients N=4,803 N=500 N=160 ARM A: Perjeta (840mg l
Slide 65: Oncology: Tecentriq lung cancer
Tecentriq Anti-PD-L1 cancer immunotherapy – lung cancer Indication Adjuvant NSCLC Neoadjuvant NSCLC Phase III Phase III Phase/study IMpower010 IMpower030 # of patients N=1,280 N=450 Following adjuvant cisplatin-based chemotherapy ARM A: Tecentriq plus platinum-based chemotherapy ARM A: Tecentriq
Slide 66: Oncology: Tecentriq lung cancer
Tecentriq Anti-PD-L1 cancer immunotherapy – lung cancer Indication 1L maintenance extensive-stage SCLC 2L NSCLC previously treated with an immune checkpoint inhibitor Phase III Phase III Phase/study IMforte1 CONTACT-01 # of patients N=450 N=366 ARM A:Platinum-etoposide + Tecentriq followed by main
Slide 67: Oncology: Tecentriq lung cancer
Tecentriq Anti-PD-L1 cancer immunotherapy – lung cancer Indication 1L NSCLC Stage IV NSCLC Phase II/III Phase Ib/III Phase/study B-FAST IMscin0011 # of patients Modular design N=371 Cohort A: ALK+ (Alecensa) Phase Ib Cohort B: RET+ (Alecensa) Dose finding, Tecentriq SC followed by Tecentriq IV
Slide 68: Oncology: Tecentriq SCCHN and melanoma
Tecentriq Anti-PD-L1 cancer immunotherapy – SCCHN and melanoma Indication First-line BRAFv600 mutation-positive metastatic or unresectable locally Adjuvant squamous cell carcinoma of the head and neck (SCCHN) advanced melanoma Phase III Phase III Phase/study IMvoke010 IMspire150 TRILOGY1 # of patien
Slide 69: Oncology: Tecentriq urothelial carcinoma
Tecentriq Anti-PD-L1 cancer immunotherapy – urothelial carcinoma High-risk non-muscle-invasive ctDNA+, high-risk muscle-invasive Indication 1L metastatic urothelial carcinoma (UC) bladder cancer (MIBC) bladder cancer (MIBC) Phase III Phase III Phase III Phase/study IMvigor130 ALBAN IMvigor011 # of p
Slide 70: Oncology: Tecentriq renal cell cancer
Tecentriq Anti-PD-L1 cancer immunotherapy – renal cell cancer Advanced renal cell carcinoma (RCC) after immune checkpoint inhibitor Indication Adjuvant renal cell carcinoma (RCC) treatment Phase III Phase III Phase/study IMmotion010 Contact-031 # of patients N=778 N=500 ARM A: Tecentriq monotherap
Slide 71: Oncology: Tecentriq hepatocellular carcinoma
Tecentriq Anti-PD-L1 cancer immunotherapy – hepatocellular carcinoma Indication 1L hepatocellular carcinoma (HCC) Adjuvant hepatocellular carcinoma (HCC) Phase III Phase III Phase/study IMbrave150 IMbrave050 # of patients N=501 N=668 ARM A: Tecentriq plus Avastin ARM A: Tecentriq plus Avastin
Slide 72: Oncology: Tecentriq breast cancer
Tecentriq Anti-PD-L1 cancer immunotherapy – breast cancer Previously untreated metastatic Indication triple negative breast cancer (TNBC) Phase III Phase III Phase/study IMpassion130 IMpassion132 # of patients N=902 N=572 ARM A: Tecentriq plus nab-paclitaxel ARM A: Tecentriq plus capecitabine or
Slide 73: Oncology: Tecentriq breast cancer
Tecentriq Anti-PD-L1 cancer immunotherapy – breast cancer Indication Neoadjuvant triple negative breast cancer (TNBC) Adjuvant triple negative breast cancer (TNBC) Phase III Phase III Phase/study IMpassion031 IMpassion030 # of patients N=333 N=2,300 ARM A: Tecentriq plus nab-paclitaxel ARM A: Te
Slide 74: Oncology: Venclexta CLL
Venclexta Novel small molecule Bcl-2 selective inhibitor – chronic lymphocytic leukemia Untreated chronic lymphocytic leukemia (CLL) Relapsed or refractory chronic lymphocytic Untreated fit chronic lymphocytic leukemia Indication patients with leukemia (CLL) (CLL) patients coexisting medical conditi
Slide 75: Oncology: Venclexta multiple myeloma
Venclexta Novel small molecule Bcl-2 selective inhibitor – multiple myeloma Indication Relapsed or refractory multiple myeloma (MM) Phase III Phase/study Phase I Phase Ib/II CANOVA # of patients N=117 N=120 N=244 Dose escalation cohort: Venclexta plus carfilzomib plus dexamethasone Venclexta p
Slide 76: Oncology: Venclexta MDS
Venclexta Novel small molecule Bcl-2 selective inhibitor – myelodysplastic syndromes Relapsed or refractory myelodysplastic Treatment-naive myelodysplastic syndromes Newly diagnosed higher-risk Indication syndromes (MDS) (MDS) myelodysplatic syndrome (MDS) Phase III Phase/study Phase Ib Phase Ib VER
Slide 77: Oncology: Polivy
Polivy (polatuzumab vedotin) ADC targeting CD79b to treat B cell malignancies Indication 1L DLBCL Phase III Phase/study POLARIX # of patients N=879 ARM A: Polivy plus R-CHP ARM B: R-CHOP Design Oncology Progression-free survival Primary endpoint FPI Q4 2017 Recruitment completed Q2 2019
Slide 78: Oncology: Rozlytrek
Rozlytrek (entrectinib) CNS-active and selective inhibitor of NTRK/ROS1 Indication Locally advanced or metastatic tumors with Locally advanced or metastatic tumors with Pediatric tumors with NTRK 1/2/3, ROS-1 ROS1 gene rearrangement NTRK1/2/3 gene rearrangement or ALK rearrangement Phase II Phase II
Slide 79: Oncology: Gavreto
Gavreto (pralsetinib, RG6396) Highly selective RET inhibitor RET+ NSCLC, thyroid cancer and Indication 1L RET fusion-positive, metastatic NSCLC other advanced solid tumors Phase I/II Phase III Phase/study ARROW AcceleRET Lung # of patients N=647 N=250 Part 1: Gavreto 30-600mg dose escalation Arm
Slide 80: Neuroscience: Ocrevus
Ocrevus (ocrelizumab, RG1594) Humanized monoclonal antibody selectively targeting CD20+ B cells Primary progressive Indication Relapsing multiple sclerosis (RMS) multiple sclerosis (PPMS) Phase III Phase III Phase III Phase/study OPERA I OPERA II ORATORIO # of patients N=821 N=835 N=732 96-week trea
Slide 81: Neuroscience: Ocrevus
Ocrevus (ocrelizumab, RG1594) Humanized monoclonal antibody selectively targeting CD20+ B cells Indication Relapsing and primary progressive multiple sclerosis (RMS & PPMS) Primary progressive multiple sclerosis (PPMS) Phase IIIb Phase IIIb Phase/study ENSEMBLE PLUS ORATORIO-HAND # of patients N=122
Slide 82: Neuroscience: Ocrevus
Ocrevus (ocrelizumab, RG1594) Humanized monoclonal antibody selectively targeting CD20+ B cells Indication Primary progressive multiple sclerosis (PPMS) Relapsing multiple sclerosis (RMS) Phase IIIb Phase IIIb Phase/study GAVOTTE MUSETTE # of patients N ~ 699 N ~ 786 120-week treatment period: 120-w
Slide 83: Neuroscience: Evrysdi
Evrysdi (risdiplam, RG7916) Oral SMN2 splicing modifier Indication Spinal muscular atrophy (SMA) Phase II/III Phase II/III Phase II Phase/study FIREFISH SUNFISH JEWELFISH # of patients N=21 (Part 1), 41 (Part 2) N=51 (Part 1), 180 (Part 2) N=174 Open-label study in infants with type 1 SMA Randomized
Slide 84: Neuroscience: Evrysdi
Evrysdi (risdiplam, RG7916) Oral SMN2 splicing modifier Indication Spinal muscular atrophy (SMA) Phase II Phase II/III Phase/study RAINBOWFISH MANATEE # of patients N=25 N=180 Open-label, single-arm, multicenter study in infants aged from birth to 6 ARM A: weeks who have been genetically diagnosed w
Slide 85: Neuroscience: Enspryng
Enspryng (satralizumab, RG6168, SA237) Anti-IL-6 receptor humanized monoclonal antibody Indication Neuromyelitis optica spectrum disorder (NMOSD) Phase III Phase III Phase/study SAkuraStar SAkuraSky # of patients N=95 N=83 Enspryng monotherapy: Add-on therapy of Enspryng: • Group A: Enspryng 120mg S
Slide 86: Neuroscience: Enspryng
Enspryng (satralizumab, RG6168, SA237) Anti-IL-6 receptor humanized monoclonal antibody Indication Generalised myasthenia gravis (MG) Myelin oligodendrocyte glycoprotein antibody disease (MOGAD) Phase III Phase III Phase/study Luminesce METEOROID # of patients N=240 N=152 • Group A: Enspryng plus st
Slide 87: Immunology: Gazyva
Gazyva (obinutuzumab) Immunology development program Indication Lupus nephritis Membranous nephropathy Phase II Phase III Phase III Phase/study NOBILITY REGENCY MAJESTY # of patients N=126 N=252 N=140 ARM A: Gazyva 1000mg IV plus mycophenolate ARM A: Gazyva 1000mg IV (6 doses through Week ARM
Slide 88: Immunology: Gazyva
Gazyva (obinutuzumab) Immunology development program Indication Systemic lupus erythematosus (SLE) Phase III Phase/study ALLEGORY # of patients N=200 • ARM A: Gazyva 1000mg IV on Day 1 and Weeks 2, 24 and 26. • ARM B: Placebo IV Immunology Design Primary endpoint • Percentage of participants who ach
Slide 89: Immunology: Actemra/RoActemra
Actemra/RoActemra (tocilizumab, RG-1569) Interleukin 6 receptor inhibitor Indication Adult hospitalised with severe COVID-19 pneumonia Phase III Phase III Phase/study COVACTA1 REMDACTA2 # of patients N=450 N=650 Arm A: Actemra plus standard of care Arm A: Remdesivir plus Actemra Arm B: Placebo
Slide 90: Immunology: Actemra/RoActemra
Actemra/RoActemra (tocilizumab, RG-1569) Interleukin 6 receptor inhibitor Indication Adult hospitalised with severe COVID-19 pneumonia Phase II Phase III Phase/study MARIPOSA EMPACTA # of patients N=100 N=379 Arm A: 8 mg/kg Actemra plus standard of care Conducted in sites known to provide critical
Slide 91: Immunology: Xolair
Xolair Humanized monoclonal antibody that selectively binds to IgE Indication Food allergy Phase III Phase/study OUtMATCH1 # of patients N=225 • Xolair by SC injection either q2w or q4w for 16 to 20 weeks Immunology Design Primary endpoint • Number of participants who successfully consume ≥600mg of
Slide 92: Ophthalmology: Susvimo (PDS)
Susvimo (PDS) First eye implant to achieve sustained delivery of a biologic medicine Indication Wet age-related macular degeneration (wAMD) Phase III Phase II+III extension Phase IIIb Phase/study Archway Portal Velodrome # of patients N=418 N=1,000 N=442 ARM A: Port delivery system with ranibizuma
Slide 93: Ophthalmology: Susvimo (PDS)
Susvimo (PDS) First eye implant to achieve sustained delivery of a biologic medicine Diabetic retinopathy (DR) without Indication Diabetic macular edema (DME) center-involved diabetic macular edema (DME) Phase III Phase III Phase/study Pagoda Pavilion # of patients N=545 N=160 ARM A: Port delivery
Slide 94: Ophthalmology: Vabysmo
Vabysmo (faricimab) Bispecific antibody to simultaneously bind Ang-2 and VEGF-A Indication Center-involving diabetic macular edema (CI-DME) Phase III Phase III Phase/study YOSEMITE RHINE # of patients N=940 N=951 ARM A: Faricimab q8w ARM A: Faricimab q8w ARM B: Faricimab PTI up to q16w ARM B
Slide 95: Ophthalmology: Vabysmo
Vabysmo (faricimab) Bispecific antibody to simultaneously bind Ang-2 and VEGF-A Indication Neovascular age related macular degeneration (nAMD) Phase III Phase III Phase/study TENAYA LUCERNE # of patients N=671 N=658 ARM A: Faricimab 6.0mg q16w flexible after 4 IDs ARM A: Faricimab 6.0mg q16w fle
Slide 96: Ophthalmology: Vabysmo
Vabysmo (faricimab) Bispecific antibody to simultaneously bind Ang-2 and VEGF-A Indication Macular edema (ME) secondary to branch retinal vein occlusion (RVO) Macular edema (ME) secondary to central retinal vein occlusion (RVO) Phase III Phase III Phase/study BALATON COMINO # of patients N=570 N=750
Slide 97: Infectious Diseases: Xofluza
Xofluza (baloxavir marboxil, RG6152, S-033188 ) Small molecule, novel CAP-dependent endonuclease inhibitor Indication Influenza Phase III Phase III Phase IIIb Phase/study miniSTONE 1 (0-1 year old) miniSTONE 2 (1- <12 years old ) CENTERSTONE N=3,160 # of patients N=30 N=176 Reduction of direct tra
Slide 98: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 99: Oncology: Ipatasertib
Ipatasertib (RG7440, GDC-0068) Highly selective small molecule inhibitor of Akt Indication Prostate cancer (PC) previously treated with 1L castration-resistant prostate cancer (CRPC) Advanced prostate cancer (PC) and solid tumors androgen receptor-targeted therapy Phase III Phase/study Phase Ib Phas
Slide 100: Oncology: Tiragolumab
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Indication 1L NSCLC PD-L1 TPS>50% 1L ES-SCLC Stage III unresectable 1L NSCLC Phase III Phase III Phase III Phase/study SKYSCRAPER-01 SKYSCRAPER-02 SKYSCRAPER-03 # of patients N=500-560 N=4
Slide 101: Oncology: Tiragolumab
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Metastatic and/or recurrent PD-L1+ Indication Neoadjuvant and adjuvant NSCLC 1L non-squamous NSCLC cervical cancer (CC) Phase II Phase II Phase II/III Phase/study SKYSCRAPER-04 SKYSCRAPER-
Slide 102: Oncology: Tiragolumab
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT 1L recurrent/metastatic PD-L1 positive Indication Locally advanced esophageal cancer (EC) 1L esophageal cancer (EC) squamous cell head and neck carcinoma (SCCHN) Phase III Phase III Phase
Slide 103: Oncology: Tiragolumab
Tiragolumab (anti-TIGIT, RG6058, MTIG7192A) Monoclonal antibody targeting the immune checkpoint inhibitor TIGIT Relapsed or refractory multiple myeloma (MM) Indication Solid tumors NSCLC or r/r B-cell NHL Phase II Phase/study Phase I Phase l CITYSCAPE # of patients N=540 N=135 N=52 Phase Ia: Dose
Slide 104: Oncology: Glofitamab
Glofitamab (CD20-TCB, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Relapsed or refractory Non-Hodgkin’s lymphoma (NHL) Phase/study Phase I Phase Ib Phase I # of patients N=700 N=140 N=18-36 Cohort 1: Single-agent dose escalation study Dose escalation and
Slide 105: Oncology: Glofitamab
Glofitamab (CD20-TCB, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Relapsed or refractory DLBCL and high-grade Indication Non-Hodgkin’s lymphoma (NHL) 2L+ SCT-ineligible DLBCL large B-cell lymphoma Phase III Phase/study Phase Ib Phase Ib STARGLO Part I: 15-60 # of
Slide 106: Oncology: Glofitamab
Glofitamab (CD20-TCB, RG6026) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 1L ctDNA high risk DLBCL Phase/study Phase II # of patients N=40 Glofitamab plus R-CHOP (glofitamab is introduced as a consolidation to R-CHOP at cycle 3-8 in patients ctDNA+ at cycle 2
Slide 107: Oncology: Mosunetuzumab
Mosunetuzumab (CD20/CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously 3L+ FL, 3L+ DLBCL & other relapsed or Indication 1L DLBCL Relapsed or refractory DLBCL refractory NHL Phase/study Phase I/II Phase Ib/II Phase Ib # of patients N=746 N=160 N=262 Dose escalation
Slide 108: Oncology: Mosunetuzumab
Mosunetuzumab (CD20/CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 1L DLBCL & 2L DLBCL following 1L induction Relapsed or refractory 2L+ FL Phase/study Phase I Phase Ib # of patients N=92 + 80 (cohort C) N=27 Cohort A: Mosunetuzumab monotherapy (aft
Slide 109: Oncology: Mosunetuzumab
Mosunetuzumab (CD20/CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication 2L+ FL Relapsed or refractory FL Relapsed or refractory CLL Phase III Phase/study Phase Ib/II Phase Ib/II CELESTIMO # of patients N=400 N=118 N=56 Arm A: Mosunetuzumab plus lenalidom
Slide 110: Oncology: Inavolisib
Inavolisib (RG6114, GDC-0077) A potent, orally available, and selective PI3Kα inhibitor PIK3CA mutant solid tumors and metastatic Indication PIK3CA-mutant HR+ metastatic breast cancer (mBC) ER+ HER2-neg breast cancer Phase III Phase/study Phase I INAVO120 # of patients N=400 N=256 Arm A: Inavolisi
Slide 111: Oncology: Giredestrant
Giredestrant (SERD (3),RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator ER+ HER2-neg Stage I-III operable breast cancer Indication ER+ HER2-neg metastatic breast cancer (mBC) Neoadjuvant ER+ breast cancer (BC) (BC) Phase II Phase/study Phase I Phase I coopERA Breast Cancer #
Slide 112: Oncology: Giredestrant
Giredestrant (SERD (3),RG6171, GDC-9545) A selective estrogen receptor degrader or downregulator 2L/3L ER+/HER2-negative Indication 1L ER+ metastatic breast cancer (mBC) Adjuvant ER+ breast cancer (BC) metastatic breast cancer (mBC) Phase II Phase III Phase III Phase/study acelERA Breast Cancer pers
Slide 113: Immunology: zinpentraxin alfa
zinpentraxin alfa (PRM-151, RG6354) Recombinant human innate immunity protein pentraxin-2 Indication Idiopathic pulmonary fibrosis (IPF) Myelofibrosis Phase III Phase/study Phase II Phase II STARSCAPE # of patients N=117 N=658 N=125 Randomized, double-blind, placebo- Randomized, double-blind, pl
Slide 114: Immunology: Crovalimab
Crovalimab (RG6107; SKY59) A humanized monoclonal antibody against complement C5 Paroxysmal nocturnal hemoglobinuria (PNH) patients switching from a Indication Paroxysmal nocturnal hemoglobinuria (PNH) C5 inhibitor Phase I/II Phase III Phase/study COMPOSER COMMODORE 1 # of patients N=59 N=250 Health
Slide 115: Immunology: Crovalimab
Crovalimab (RG6107; SKY59) A humanized monoclonal antibody against complement C5 Paroxysmal nocturnal hemoglobinuria (PNH) Paroxysmal nocturnal hemoglobinuria (PNH) Indication C5 inhibitor naive patients C5 inhibitor naive patients (China only) Phase III Phase III Phase/study COMMODORE 2 COMMODORE 3
Slide 116: Immunology: Crovalimab
Crovalimab (RG6107; SKY59) A humanized monoclonal antibody against complement C5 Atypical hemolytic uremic syndrome (aHUS) Atypical hemolytic uremic syndrome (aHUS) Indication study 1 - adults study 2 - paediatrics Phase III Phase III Phase/study COMMUTE-a COMMUTE-p # of patients N=90 N=35 Single-ar
Slide 117: Immunology: Crovalimab
Crovalimab (RG6107; SKY59) A humanized monoclonal antibody against complement C5 Sickle cell disease (SCD) Sickle cell disease (SCD) Indication acute treatment chronic VOC prevention Phase Ib Phase IIa Phase/study CROSSWALK-a CROSSWALK-c # of patients N=30 N=90 Arm A: Crovalimab Arm A: Crovalimab Ar
Slide 118: Immunology: Mosunetuzumab
Mosunetuzumab (CD20/CD3, RG7828) Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously Indication Systemic lupus erythematosus (SLE) Phase/study Phase I # of patients N=50 ARM A: Mosunetuzumab SC on either Day 1 or on Days 1 and 8 ARM B: fractionated (divided) dose of mosunetuz
Slide 119: Neuroscience: Crenezumab
Crenezumab (RG7412) Humanized monoclonal antibody targeting all forms of Ab Indication Alzheimer’s prevention initiative (API) Colombia Phase II Phase/study Cognition study # of patients N=252 ARM A: PSEN1 E280A mutation carriers receive crenezumab SC ARM B: PSEN1 E280A mutation carriers receive
Slide 120: Neuroscience: Gantenerumab
Gantenerumab (RG1450) Fully human monoclonal antibody binding aggregated forms of Aß Indication Prodromal to mild Alzheimer’s disease Phase III Phase III Phase II Phase/study GRADUATE 1 GRADUATE 2 GRADUATION # of patients N=1,016 N=1,016 N=192 104-week SC treatment period: 104-week SC treatment peri
Slide 121: Neuroscience: Gantenerumab
Gantenerumab (RG1450) Fully human monoclonal antibody binding aggregated forms of Aß Indication Prodromal Alzheimer’s disease Mild Alzheimer’s disease Early Alzheimer’s disease Phase II/III Phase III Phase III Phase/study SCarlet RoAD1 Marguerite RoAD1 SKYLINE2 # of patients N=799 N=389 N=1200 104-w
Slide 122: Neuroscience: Tominersen
Tominersen (RG6042, HTT ASO ) Antisense oligonucleotide (ASO) targeting human HTT mRNA Indication Huntington’s disease Phase II Phase/study Phase I/IIa OLE # of patients N=46 N=46 Multiple ascending doses of tominersen administered intrathecally to adult Patients from phase I are enrolled into O
Slide 123: Neuroscience: Tominersen
Tominersen (RG6042, HTT ASO ) Antisense oligonucleotide (ASO) targeting human HTT mRNA Indication Huntington’s disease Phase III Phase III Phase/study Generation HD1 GEN-EXTEND # of patients N=791 N=1,050 ARM A: Tominersen 120mg q2w OLE study in patients participating in prior Roche and Genentech
Slide 124: Neuroscience: Fenebrutinib
Fenebrutinib (RG7845, GCD-0853) Highly selective and reversible (noncovalent) bruton tyrosine kinase Indication Primary progressive multiple sclerosis (PPMS) Relapsing multiple sclerosis (RMS) Phase III Phase III Phase III Phase/study FENtrepid FENhance 1 FENhance 2 # of patients N=946 N=736 N=736
Slide 125: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 126: pRED oncology development programs -1
pRED oncology development programs -1 Molecule Indication Phase # of patients Status CT Identifier Oncology FPI Q2 2018 Solid tumors I ~150 Data presented at ESMO 2020 FAP-4-1BBL (RG7827) Recruitment completed Q2 2021 FPI Q3 2021 3L+ MSS mCRC Ib 80 NCT04826003 Combination study with cibisatamab Part
Slide 127: pRED oncology development programs -2
pRED oncology development programs -2 Molecule Indication Phase # of patients Status CT Identifier Oncology Solid tumors I 110 FPI Q4 2019 NCT04158583 CD25 (RG6292) Advanced and metastatic solid Part I: FPI Q1 2021 I 160 NCT04642365 tumors Part II: FPI Q4 2021 Anti-GPRC5D (RG6234) Multiple myeloma I
Slide 128: pRED neuroscience development programs
pRED neuroscience development programs Molecule Indication Phase # of patients Status CT Identifier Neuroscience Brain Shuttle-gantenerumab (BS- Alzheimer's disease IIa ~120 FPI Q1 2021 NCT04023994 gantenerumab, RG6102) Brain Shuttle-CD20 (BS-CD20, ISRCTN16295 Multiple sclerosis I 30 FPI Q3 2021 RG6
Slide 129: pRED neuroscience development programs
pRED neuroscience development programs Molecule Indication Phase # of patients Status CT Identifier Neuroscience NME (RG6289) Alzheimer's disease I 138 FPI Q4 2021 NME (RG6163) Psychiatric disorders I 84 FPI Q1 2022 Partner: 1Prothena; BS=Brain Shuttle 129
Slide 130: pRED immunology and ophthalmology development programs
pRED immunology and ophthalmology development programs Molecule Indication Phase # of patients Status CT Identifier Immunology selnoflast Inflammation Ib 18 FPI Q4 2021 (NLRP3i, RG6418) Ophthalmology I 90 FPI Q3 2019 DOVETAIL NCT05151744 II 160 FPI Q4 2021 NME (RG6179)1 DME (BARDERNAS) NCT05151731 I
Slide 131: pRED infectious diseases development programs
pRED infectious diseases development programs Molecule Indication Phase # of patients Status CT Identifier Infectious Diseases FPI Q4 2016 TLR7 agonist (3) (RG7854) Chronic hepatitis B I 150 NCT02956850 Data presented at APASL 2019 FPI Q4 2016 I/II 192 NCT02952924 Data presented at EASL 2018, 2019 &
Slide 132: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 133: gRED oncology development programs
gRED oncology development programs Molecule Indication Phase # of patients Status CT Identifier Oncology Metastatic solid tumors with KRAS KRAS G12C (RG6330) I 270 FPI Q3 2020 NCT04449874 G12C mutation cevostamab FPI Q3 2017 R/R multiple myeloma I 300 NCT03275103 (anti-FcRH5 x CD3; RG6160) Data pres
Slide 134: gRED immunology and ophthalmology development programs
gRED immunology and ophthalmology development programs Molecule Indication Phase # of patients Status CT Identifier Immunology efmarodocokin alfa aGVHD lb 18 FPI Q4 2020 NCT04539470 (IL-22Fc, RG7880) FPI Q1 2020 Inflammatory bowel disease I 68 EUDRACT2019 NME (RG6287, GDC-8264) Recruitment completed
Slide 135: gRED neuroscience and metabolic diseases development programs
gRED neuroscience and metabolic diseases development programs Molecule Indication Phase # of patients Status CT Identifier Neuroscience FPI Q4 2017 Prodromal to mild NCT03289143 II 457 Primary endpoint not met Q3 2020 Alzheimer’s disease (TAURIEL) Data presented at CTAD 2020 semorinemab (RG6100)1 FP
Slide 136: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 137: Hemophilia A: Unique gene therapy platform
Hemophilia A Unique gene therapy platform SPK-8011 SPK-8016 Molecule (RG6357) (RG6358) Indication Hemophilia A Hemophilia A with inhibitors to Factor VIII Phase/study Phase I Phase I/II Phase I/II # of patients N=100 N=30 N=30 Long term follow up study of patients who Gene transfer, dose-finding
Slide 138: Pompe disease: Unique gene therapy platform
Pompe disease Unique gene therapy platform SPK-3006 Molecule (RG6359) Indication Pompe disease Phase I/II Phase/study RESOLUTE # of patients N=20 Gene transfer study for late-onset Pompe disease Metabolic Diseases Design Safety Primary endpoint Status FPI Q4 2020 CT Identifier NCT04093349 138
Slide 139: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 140: Geographical sales split by Divisions and Group
Geographical sales split by Divisions and Group* CHFm Q1 2021 Q1 2022 % change CER Pharmaceuticals Division 10,600 11,159 +6 United States 5,292 5,489 +2 Europe 2,175 2,072 -1 Japan 852 1,337 +69 International 2,281 2,261 0 Diagnostics Division 4,330 5,286 +24 United States 947 1,465 +51 Europe 1,70
Slide 141: Pharma Division sales Q1 2022
Pharma Division sales Q1 2022 Top 20 products Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 1,449 18 1,050 12 280 34 - - 119 29 Perjeta 993 1 362 -1 228 -21 59 -1 344 32 Hemlibra 853 30 520 28 170 31 84 15 79 63 Tecentriq 825 8 446 10 183 14 107
Slide 142: Pharma Division sales Q1 2022
Pharma Division sales Q1 2022 Product sales Pharmaceuticals Division Global US Europe Japan International CHFm % CER CHFm % CER CHFm % CER CHFm % CER CHFm % CER Ocrevus 1,449 18 1,050 12 280 34 - - 119 29 Perjeta 993 1 362 -1 228 -21 59 -1 344 32 Hemlibra 853 30 520 28 170 31 84 15 79 63 Tecentriq 8
Slide 143: Pharma Division CER sales growth in %
Pharma Division CER sales growth1 in % Global top 20 products Q1/21 Q2/21 Q3/21 Q4/21 Q1/22 Ocrevus 16 31 7 25 18 Perjeta 2 7 2 3 1 Hemlibra 33 58 37 38 30 Tecentriq 26 31 23 17 8 Actemra / RoActemra 22 12 57 21 3 Herceptin -35 -35 -26 -6 -19 Ronapreve - - - - 272 Avastin -40 -40 -37 -30 -32 MabTher
Slide 144: Pharma Division CER sales growth in %
Pharma Division CER sales growth1 in % Top 20 products by region US Europe Japan International Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Ocrevus 28 0 23 12 40 36 26 34 - - - - 41 35 51 29 Perjeta -3 2 -2 -1 2 -8 -8 -21 -2 0 -3 -1 34 16 24 32 Hemlibra 49 36 33 28 123 26 53 31 21 29 30 15 92 138
Slide 145: CER sales growth (%)
CER sales growth (%) Quarterly development 2021 vs. 2020 2022 vs. 2021 Q1 Q2 Q3 Q4 Q1 Pharmaceuticals Division -9 4 5 14 6 United States -14 0 0 8 2 Europe -6 15 1 19 -1 Japan -7 7 60 46 69 International 0 4 2 9 0 Diagnostics Division 55 48 18 8 24 Roche Group 3 14 8 12 11 CER=Constant Exchange Rate
Slide 146: Ocrevus
Ocrevus CHFbn Global sales CER growth Regional sales CER growth 1.6 +18% US +12% 1.4 1.2 1.0 0.8 Europe +34% 0.6 0.4 International +29% 0.2 0.0 Q1 19 Q1 20 Q1 21 Q1 22 Q1 2022 sales of CHF 1,449m • US: Moving into earlier lines displacing orals; COVID-19 impact still felt • EU: Moving into earlier l
Slide 147: Perjeta
Perjeta Global sales CER growth Regional sales CER growth CHFbn 1.2 +1% US -1% 1.0 Europe -21% 0.8 Japan -1% 0.6 0.4 International +32% 0.2 0.0 Q1 19 Q1 20 Q1 21 Q1 22 Q1 2022 sales of CHF 993m • US: Cannibalization from Phesgo • EU: Cannibalization from Phesgo • International: Patients with residua
Slide 148: Hemlibra
Hemlibra Global sales CER growth Regional sales CER growth CHFbn 1.0 +30% US +28% Europe +31% 0.8 0.6 Japan +15% 0.4 International +63% 0.2 0.0 Q1 19 Q1 20 Q1 21 Q1 22 Q1 2022 sales of CHF 853m • US: Continued share gains in non-inhibitor patients • EU: Continued share gains in non-inhibitor severe
Slide 149: Tecentriq
Tecentriq Global sales CER growth Regional sales CER growth CHFbn 1.0 +8% US +10% 0.8 Europe +14% 0.6 Japan -5% 0.4 International 0% 0.2 0.0 Q1 19 Q1 20 Q1 21 Q1 22 Q1 2022 sales of CHF 825m • US: Growth driven by first-in-class launches in 1L HCC, 1L SCLC and adjuvant PDL1+ NSCLC • EU: Growth drive
Slide 150: Actemra / RoActemra
Actemra / RoActemra Global sales CER growth Regional sales CER growth CHFbn 1.0 +3% US +22% 0.8 Europe -4% 0.6 0.4 Japan +12% 0.2 International -30% 0.0 Q1 19 Q1 20 Q1 21 Q1 22 Q1 2022 sales of CHF 792m • US: Increased demand for SC formulation (home administration); Slowing demand for COVID-19 • EU
Slide 151: Herceptin
Herceptin Global sales CER growth Regional sales CER growth CHFbn 2.0 -19% US -26% Europe -13% 1.6 Japan -30% 1.2 0.8 International -18% 0.4 0.0 Q1 19 Q1 20 Q1 21 Q1 22 Q1 2022 sales of CHF 607m • US: Biosimilar erosion with slowing momemtun; Switching of patients with residual disease to Kadcyla; C
Slide 152: Ronapreve
Ronapreve Global sales CER growth Regional sales CER growth CHFbn 272% 0.8 International n/a 0.6 Europe -61% 0.4 Japan n/a 0.2 0.0 Q1 19 Q1 20 Q1 21 Q1 22 Q1 2022 sales of CHF 587m • EU: Slowing sales as Ronapreve has limited activity against Omicron variant • Japan: Additional sales to the governme
Slide 153: Avastin
Avastin Global sales CER growth Regional sales CER growth CHFbn 2.0 -32% US -39% Europe -56% 1.6 1.2 Japan -12% 0.8 International -23% 0.4 0.0 Q1 19 Q1 20 Q1 21 Q1 22 Q1 2022 sales of CHF 581m • US: Decline due to biosimilars; erosion momentum slowing • EU: Decline due to biosimilars; erosion moment
Slide 154: Rituxan / MabThera
Rituxan / MabThera CHFbn Global sales CER growth Regional sales CER growth 2.0 -21% US -20% 1.6 Europe -19% 1.2 Japan -15% 0.8 International -23% 0.4 0.0 Q1 19 Q1 20 Q1 21 Q1 22 Q1 2022 sales of CHF 564m • US: Decline due to biosimilars; erosion momentum slowing • EU: Decline due to biosimilars; ero
Slide 155: Kadcyla
Kadcyla Global sales CER growth Regional sales CER growth CHFbn +9% 0.6 US 0% 0.4 Europe +8% 0.2 Japan +28% International +26% 0.0 Q1 19 Q1 20 Q1 21 Q1 22 Q1 2022 sales of CHF 511m • US: Growth in adjuvant eBC; share decline in metastatic BC due to competition • EU: Strong uptake in adjuvant eBC in
Slide 156: Xolair
Xolair Global sales CER growth Regional sales CER growth CHFbn 0.6 +9% 0.4 US +9% 0.2 0.0 Q1 19 Q1 20 Q1 21 Q1 22 Q1 2022 sales of CHF 456m • US: Xolair remains market leader in growing biologics asthma market; Growth driven by chronic idiopathic urticaria (CIU) CER=Constant Exchange Rates 156
Slide 157: Alecensa
Alecensa Global sales CER growth Regional sales CER growth CHFbn 0.4 +23% US +25% 0.3 Europe +5% 0.2 Japan +7% 0.1 International +45% 0.0 Q1 19 Q1 20 Q1 21 Q1 22 Q1 2022 sales of CHF 361m • US: New patient share in 1L at around 70% • EU: EU-5 new patient share in 1L at around 70% • Japan: New patien
Slide 158: Lucentis
Lucentis Global sales CER growth Regional sales CER growth CHFbn 0.5 -26% 0.4 0.3 US -26% 0.2 0.1 0.0 Q1 19 Q1 20 Q1 21 Q1 22 Q1 2022 sales of CHF 256m • Declining market share as market dynamics impacted by new entrances and upcoming biosimilars • First biosimilar expected by mid 2022 CER=Constant
Slide 159: TNKase / Activase
TNKase / Activase Global sales CER growth Regional sales CER growth CHFbn 0.4 -20% US -21% 0.3 0.2 0.1 International -3% 0.0 Q1 19 Q1 20 Q1 21 Q1 22 Q1 2022 sales of CHF 247m • US: Sales impacted by COVID-19 and purchasing patterns CER=Constant Exchange Rates 159
Slide 160: Esbriet
Esbriet CHFbn Global sales CER growth Regional sales CER growth 0.4 -6% US -4% Europe -5% 0.3 0.2 International -36% 0.1 0.0 Q1 19 Q1 20 Q1 21 Q1 22 Q1 2022 sales of CHF 241m • US: Reduction in new patients being diagnosed and initiated due to COVID-19 • EU: Reduction in new patients being diagnosed
Slide 161: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 162: Q1 2022: Diagnostics Division CER growth
Q1 2022: Diagnostics Division CER growth By Region and Customer Area (vs. 2021) Reported Restatement3 Global EMEA¹ NOA APAC LATAM Global EMEA¹ NOA APAC LATAM CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER 2,3 Core Lab 1,873 8 657 8 347 3 736 9 133
Slide 163: Diagnostics Division quarterly sales and CER growth
Diagnostics Division quarterly sales and CER growth1 Reported Restatement3 Q1 21 Q2 21 Q3 21 Q4 21 Q1 22 Q1 21 Q2 21 Q3 21 Q4 21 Q1 22 CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER CHFm %CER Core Lab2,3 1,765 31 1,961 36 1,884 12 1,863 10 1,873 8 1,786 31
Slide 164: Q1 2022: Diagnostics Division regional sales
Q1 2022: Diagnostics Division regional sales Growth driven by North America and Asia Pacific Sales YTD CHFm & % of total sales Sales growth at CER Total YTD Sales = 5,286 Diagnostics Division 24% GLOBAL 284 / 2% EMEA* 5% 59% NOA 1,902 / APAC 1,395 / 34% 36% 27% 9% LATAM 1,705 / 32% EMEA* NOA APAC LA
Slide 165: Core Lab
Core Lab 2022 vs. 2021 CHFbn CER growth +8% 2.0 -5% 1.6 +8% 1.2 0.8 +11% 0.4 0.0 Q1 2020 Q1 2021 Q1 2022 Immunodiagnostics Clinical Chemistry Other CER=Constant Exchange Rates; underlying growth of Core Lab excluding Roche Information Solutions: +8% 165
Slide 166: Molecular Lab
Molecular Lab 2022 vs. 2021 CHFbn CER growth +21% 1.2 +62% +7% 0.8 +29% -7% +7% 0.4 +31% 0.0 Q1 2020 Q1 2021 Q1 2022 Virology Blood Screening MD Systems Microbiology Cervical Cancer qPCR&NAP Other CER=Constant Exchange Rates 166
Slide 167: Pathology Lab
Pathology Lab 2022 vs. 2021 CHFbn CER growth +14% 0.3 +19% -2% 0.2 +14% 0.1 0.0 Q1 2020 Q1 2021 Q1 2022 Advanced Staining Primary Staining Companion Diagnostics CER=Constant Exchange Rates 167
Slide 168: Diabetes Care
Diabetes Care 2022 vs. 2021 CHFbn CER growth -7% 0.4 +10% -8% 0.2 0.0 Q1 2020 Q1 2021 Q1 2022 Blood Glucose Monitoring Other CER=Constant Exchange Rates 168
Slide 169: Point of Care
Point of Care 2022 vs. 2021 CHFbn CER growth +84% 1.5 +83% +1% -8% 1.0 +107% 0.5 0.0 Q1 2020 Q1 2021 Q1 2022 Clinical Chem. & Immunodiagn. Hospital Glucose Coagulation & Urinalysis POC MDx CER=Constant Exchange Rates 169
Slide 170: Roche Group development pipeline
Roche Group development pipeline Marketed products development programmes Roche Pharma global development programmes Roche Pharma research and early development (pRED) Genentech research and early development (gRED) Spark Pharma sales appendix Diagnostics sales appendix Foreign exchange rates inform
Slide 171: CHF/USD
CHF/USD Monthly averages 1.00 0.90 0% 0.80 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2021 2022 Year-To-Date averages 1.00 0.90 2% 0.80 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2021 2022 171
Slide 172: CHF/USD
CHF/USD 1.00 Mar YTD 2022 1% 0.98 0.96 0.94 0.92 0.90 0.88 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec avg full year 2021 avg full year 2022 monthly avg 2021 monthly avg 2022 172
Slide 173: CHF/EUR
CHF/EUR Monthly averages 1.10 -7% 1.05 1.00 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2021 2022 Year-To-Date averages 1.13 1.08 -5% 1.03 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 2021 2022 173
Slide 174: CHF/EUR
CHF/EUR 1.12 Mar YTD 2022 -4% 1.10 1.08 1.06 1.04 1.02 1.00 Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec avg full year 2021 avg full year 2022 monthly avg 2021 monthly avg 2022 174
Slide 175: Average CHF Exchange Rates
Average CHF Exchange Rates Mar YTD Mar YTD Mar YTD 2022 vs. Mar YTD 2021 2022 2021 USD 0.92 0.90 2% EUR 1.04 1.09 -5% JPY 0.80 0.85 -7% -10% -5% 0% 5% 10% 175
Slide 176: Exchange rate impact on sales growth
Exchange rate impact on sales growth Q1 2022: negative impact of JPY and EUR, positive impact of USD Development of average exchange rates versus prior year period CHF / USD 2.2% CHF / EUR -4.9% CHF / JPY -6.9% Difference in CHF / CER -1.0% 0.0% 0.0% 0.0% growth 11.2% 10.2% Sales growth 2022 vs. 202
Slide 177: Doing now what patients need next
Doing now what patients need next